Product Code: GTI
FDA class 2
21 CFR 866.3390
Antisera, Fluorescent, All Groups, N. Meningitidis
Microbiology
The Antisera, Fluorescent, All Groups, N. Meningitidis is a fluorescent antiserum used in immunofluorescence assays to detect Neisseria meningitidis across all serogroups in clinical specimens, aiding in the diagnosis of bacterial meningitis. As an FDA Class 2 device, it presents moderate risk and requires 510(k) premarket clearance. The product code is GTI, regulated under 21 CFR 866.3390 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
8
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Basic Information
- Product Code
- GTI
- Device Class
- FDA class 2
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920274 | DIRECTIGEN NEISSERIA MENINGITIDIS TEST | Mar 18, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K841308 | DIRECTIGEN MENNINGITIS TEST KIT | May 02, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |